Regulatory & Legal Counsel (IRB Specialization)
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
This subcontract opportunity, titled Regulatory and Legal Counsel with an IRB Specialization, seeks a provider to deliver specialized legal expertise for prime contractors working on NIH/NCATS SMART IRB projects. The primary objective is to ensure strict compliance with the Common Rule under 45 C.F.R. Part 46. Key responsibilities include updating the SMART IRB authorization agreement to align with current federal regulations and policies, as well as providing legal guidance and responses to the user community. The selected contractor will be responsible for delivering updated authorization agreements and formal legal opinion memos. This requirement is associated with the National Institutes of Health Nida under the Department of Health and Human Services, falling under NAICS code 541110. Interested parties should note the response deadline of November 13, 2026.
General Info
Place of Performance
MD, USASet-Aside
Documents
This scope was carved out of 75N98026Q00287.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
SMART IRB Governance, Administration, and Operations Support (GAOS)
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Timeline
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Organization & Contact Information
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